False Alarms in Wearable Cardioverter Defibrillators-A Relevant Issue or an Insignificant Observation

Background: The wearable cardioverter defibrillator (WCD) has emerged as a valuable tool used for temporary protection from sudden cardiac death. However, since the WCD uses surface electrodes to detect arrhythmias, it is susceptible to inappropriate detection. Although shock conversion rates for the WCD are reported to be high for detected events, its efficacy in clinical practice tends to be degraded by patient noncompliance. Reasons for this include wearer discomfort and frequent false alarms, which may interrupt sleep and generate anxiety. Up to now, data on the incidence of false alarms emitted by the WCD and their predictors are rare. Objectives: The aim of our study was to assess the relationship between both artifact sensing and episode misclassification burden and wearing compliance in patients with a WCD (ZOLL LifeVest™ 4000 system, ZOLL CMS GmbH, Cologne, Germany). Methods and Results: We conducted a single-center retrospective observational study, analyzing patients with a WCD prescribed at our institution. A total of 134 patients (mean age 51.7 ± 13.8 years, 79.1% male) were included. Arrhythmia recordings were analyzed and categorized as non-sustained ventricular tachycardia, sustained ventricular tachycardia or fibrillation, artifact sensing or misclassified episodes. Indication for WCD prescription was both primary and secondary prophylaxis. A total of 3019 false WCD alarms were documented in 78 patients (average number of false alarms 38.7 ± 169.5 episodes per patient) over a mean WCD wearing time of 71.5 ± 70.9 days (daily WCD wearing time 20.2 ± 5.0 h). In a total of 78 patients (58.2% of the study population), either artifact sensing (76.9%), misclassified episodes (6.4%), or both (16.7%) occurred. Misclassified episodes included sinus tachycardias, atrial flutter, atrial fibrillation, premature ventricular contractions (PVCs), and intermittent bundle branch block. A multiple linear regression identified loop diuretics (regression coefficient [B] -0.11; 95% CI -0.21-(-0.0001); p = 0.049), angiotensin receptor-neprilysin inhibitors (ARNIs) (B -0.11; 95% CI 0.22-(-0.01); p = 0.033), and a higher R-amplitude of the WCD baseline electrocardiogram (ECG) (B -0.17; 95% CI -0.27-(-0.07); p = 0.001) as independent predictors for a lower number of artifact episodes per day. In addition, atrial fibrillation (B 0.05; 95% CI 0.01-0.08; p = 0.010), and calcium antagonists (B 0.07; 95% CI 0.02-0.12; p = 0.012) were independent predictors for increased numbers of misclassified episodes per day, while beta-blockers seemed to reduce them (B -0.06; 95% CI -0.10-(-0.01); p = 0.013). Patients terminated 61.0% of all false alarms manually by pressing the response button on average 1.9 times per false alarm with overall 3.6 manual terminations per affected patient per month. Conclusions: In conclusion, false alarms from the ZOLL LifeVest™ system were frequent, with artifact sensing being the most common cause. Hence, the occurrence of false alarms represents a significant side effect of WCD therapy, and efforts should be made to minimize false alarms.